Occlusion of fallopian tubes in vertebrate subject

ABSTRACT

According to one claim of the invention, a method for occluding a fallopian tube in a vertebrate subject is described, which comprises comprising transcervically delivering a solid blocking material into the fallopian tube. In various embodiments, a fluid sealing material is delivered along with the solid blocking material. Other claims of the invention pertain to articles of manufacture, delivery devices and kits for use in occluding the fallopian tubes of a vertebrate subject.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/737,004, filed Jan. 9, 2013 entitled “OCCLUSION OF FALLOPIAN TUBES INA VERTEBRATE SUBJECT”, which is a continuation of U.S. application Ser.No. 12/782,958, filed May 19, 2010 entitled “OCCLUSION OF FALLOPIANTUBES IN A VERTEBRATE SUBJECT”, which claims priority from U.S.provisional application 61/180,270, filed May 21, 2009, each of which isincorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The present invention relates, among other things, to methods, articlesof manufacture, devices and kits for use in occluding fallopian tubes ina vertebrate subject.

BACKGROUND INFORMATION

Tubal ligation is a common method for the prevention of unwantedpregnancy. For example, a commonly used method is to tie off or clampthe fallopian tube under laparoscopy or mini-laparoscopy surgicalprocedures. Another approach is to tie each fallopian tube in twolocations and cut the intermediate section. Other methods of ligationare electrodesiccation of the tubes to achieve ligation. There are risksof injury, scarring, cost, and recovery time associated with suchsurgical procedures.

Fallopian tubal ligation also can be achieved through hysteroscopicprocedures. Essure microinserts are made of nitinol wrapped with dacronand are used to block the fallopian tubes once tissue in-growthcompletely blocks the fallopian tube. This hysteroscopic method is noteffective immediately and a follow up confirmatory test after threemonths is required to ensure fallopian tubes are completely blocked. Inthe meantime alternative birth control is required. Other proceduresinvolve the injection of various compositions within each of thefallopian tubes to block the tubes. In still other techniques,radiofrequency energy is used to thermally damage the fallopian tube,causing scarring, which occludes the tube.

SUMMARY OF THE INVENTION

According to one aspect of the invention, a method for occluding afallopian tube in a vertebrate subject is described, which comprisestranscervically delivering a solid blocking material (e.g., an opensolid blocking material, for instance, a filamentous blocking materialsuch as a mesh, suture coil, etc.) into the fallopian tube. In variousembodiments, a fluid sealing material is delivered along with the solidblocking material.

Other aspects of the invention pertain to articles of manufacture,delivery devices and kits for use in occluding the fallopian tubes of avertebrate subject.

Advantages of the present inventions include the fact that fallopiantube of a subject may be occluded with a composition that blocks spermmovement and promotes tissue in-growth such that a permanent occlusionis ultimately formed.

These and other aspects, embodiments and advantages of the presentinvention will become readily apparent to those of ordinary skill in theart upon review of the Detailed Description to follow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D are schematic illustrations showing methods for introducinginto a fallopian tube a solid blocking material or a solid blockingmaterial in combination with a fluid sealing material, in accordancewith an embodiment of the invention.

FIGS. 2A-2D are schematic illustrations showing methods for introducinginto a fallopian tube a solid blocking material in combination with afluid sealing material, in accordance with an embodiment of theinvention.

FIG. 3A is a detail of an edge portion of a rectangular knotted mesh,showing tanged and de-tanged areas, in accordance with an embodiment ofthe invention.

FIG. 3 is a schematic perspective view of a rectangular mesh material,in accordance with an embodiment of the invention.

FIGS. 4-8 are schematic perspective views illustrating various ways inwhich a rectangular mesh like that of FIG. 3 can be oriented, inaccordance with various embodiments of the invention.

FIG. 9 is a schematic perspective view of the distal end of the deliverydevice of FIG. 10A, upon partial retraction of the sheath of thedelivery device, in accordance with an embodiment of the invention.

FIG. 10A is a schematic perspective view of a delivery device, inaccordance with an embodiment of the invention.

FIG. 10B is a view of the delivery device of FIG. 10A upon disassembly,in accordance with an embodiment of the invention.

FIG. 11 is a schematic perspective view of a mesh, in accordance with anembodiment of the invention.

FIG. 12 is a schematic perspective view of a mesh, in accordance withanother embodiment of the invention.

FIG. 13 is a schematic perspective view of a mesh assembly, inaccordance with an embodiment of the invention.

FIG. 14A is a schematic perspective view of a delivery device, inaccordance with an embodiment of the invention.

FIG. 14B is a view of the delivery device of FIG. 14A upon disassembly,in accordance with an embodiment of the invention.

FIGS. 15A-15H are schematic perspective views of various sheet-like meshdesigns, in accordance with various embodiments of the invention.

FIGS. 16A and 16B are schematic perspective views of twothree-dimensional mesh configurations, in accordance with twoembodiments of the invention.

FIG. 17 is a schematic illustration of a system for placement of one ormore meshes in a fallopian tube of a patient, in accordance with anembodiment of the invention.

FIGS. 18-20 are schematic illustrations showing how meshes can be placedin a fallopian tube of a patient in various specific orientations, inaccordance with various embodiment of the invention.

FIG. 21 is a schematic illustration showing the placement of a mesh andsuture loop in a fallopian tube of a patient, in accordance with anembodiment of the invention.

FIG. 22 is a schematic illustration showing the placement of threemeshes in a fallopian tube of a patient, in accordance with anembodiment of the invention.

DETAILED DESCRIPTION

The present invention relates, among other things, to methods, devices,articles of manufacture and kits for use in permanently occludingfallopian tubes in a vertebrate subject, more preferably a mammaliansubject, and even more preferably a human subject, with a solid blockingmaterial. (A typical human fallopian tube measures approximately 10 cmlong and 0.7 cm in diameter.)

In one aspect of the invention, an open blocking material, moreparticularly, a filamentous blocking material, is employed as the solidblocking material and inserted into a fallopian tube of a subject viatranscervical access using an elongated device which includes deliverychamber from which the filamentous blocking material can be released.

Referring now to FIG. 1A, in accordance with one aspect of theinvention, an assembly is shown which includes an elongated device witha delivery channel 30 and a solid blocking material 10. The deliverychannel 30 may be, for example, a working channel of any commerciallyavailable hysteroscope, or it may be the lumen of a catheter deliverytube, among other options. Inside the delivery channel 30 is provided aplunger 35, which can be used to advance the blocking material 10 out ofthe delivery channel 30 and into a fallopian tube 40 of a subject.

The blocking material is inserted into the fallopian tube of a subjectto occlude the fallopian tube. The blocking material may be made, forexample, of any suitable biocompatible material, which can be implantedpermanently. It is preferably stable in both chemically and inmechanical dimension, so that it keeps the fallopian tube sealedpermanently. The material also preferably promotes rapid scar tissueformation, with the blocking material being used as a scaffold fortissue in-growth, which results in permanent occlusion of the fallopiantube. Thus, it is preferred for such a blocking material to havenumerous spaces (e.g., pores) to promote quick and permanent scar tissueformation.

For example, in some embodiments, the blocking material may compriserandomly coiled threads (e.g., metallic or polymeric treads) or one ormore threads pre-formed into a 3-dimensional shape, for example, a shapeof circular, oval or annular cross-section (e.g., a ball, cylinder,etc.).

In other embodiments, the blocking material may comprise a fabric,preferably a mesh (e.g., a polymeric or metallic mesh). Meshes inaccordance with the present invention include woven meshes and non-wovenmeshes (including knitted meshes, felt meshes and spunbound meshes,among others). Meshes in accordance with the present inventionpreferably have inter-filament spaces (pores) that typically range inwidth from 0.01 mm to 5 mm (e.g., 0.01 mm to 0.1 mm to 0.5 mm to 1 mm to3 mm to 5 mm), more typically 0.5 to 3 mm.

Mesh widths and lengths for the practice of the invention can varywidely. However, for sheet-like meshes of relatively similar length andwidth (e.g., circular, polygonal, etc.), typical widths vary from 1 to100 mm (e.g., 1 to 2 to 5 to 10 to 20 to 50 to 75 to 100 mm), moretypically 10 to 20 mm, while for elongated sheet-like meshes (e.g.,rectangular strips, etc.), typical widths vary from 2 to 20 mm (e.g., 2to 3 to 5 to 8 to 10 to 15 to 20 mm) and typical lengths vary from 20 to60 mm (e.g., 20 to 30 to 40 to 50 to 60 mm), more typically 30 to 50 mm,among other possibilities.

Meshes in accordance with the present invention preferably havefilaments that range in diameter from 0.025 to 0.625 mm (0.025 to 0.05to 0.10 to 0.25 to 0.50 to 0.625 mm), more typically 0.05 to 0.25 mm.Filaments for forming meshes in accordance with the present inventionare preferably polymeric filaments which remain intact in vivo (i.e.,biostable polymeric filaments), and include those formed from (a)polyolefins, including homopolymers and copolymers of C1-C8 alkenes, forexample, polypropylene, (b) fluoropolymers, including homopolymers andcopolymers of C1-C8 alkenes in which one or more hydrogen atoms aresubstituted with fluorine, for example, polytetrafluoroethylene andpolyvinylidene fluoride, and (c) biostable polyesters, including, forexample, polyethylene terephthalate, among various other polymers.

In certain embodiments, the blocking material is rendered radiopaque(e.g., by including metallic particles in the material, by metal platingthe material, etc.) to facilitate location confirmation and follow up.

Moreover, in various embodiments, it is desirable for the blockingmaterial (e.g., threads, meshes, etc.) to have sharp edges which areable to cut and/or penetrate the inner lumen of the fallopian tube,thereby increasing the resistance between the blocking material and thefallopian tube wall (i.e., anchoring the blocking material) while alsostimulating scar tissue formation.

For example, where a mesh is used as a blocking material it may betanged to anchor the mesh against the inner surface of the fallopiantube and promote scarring. Tangs are the strands of fibers that areexposed on the edge of a mesh and are created when a mesh is cut. Insome embodiments, a portion of a mesh may be de-tanged to allow it to berepositioned within the fallopian tube. In other embodiments the entiremesh may be de-tanged. Such a de-tanged mesh would have the option ofbeing removed or repositioned before tissue in-growth. The mesh may needto be removed due to infection or other complications.

In some embodiments, the blocking material may be oriented or compactedby the delivery device during implantation to totally occlude the bodilytube. In some embodiments, the mesh is preformed by prepackaging themesh in a delivery device, for example, in a particular orientation. Insome embodiments, the blocking material is preformed in a particularstand-alone shape.

Where preformed in a device or in a particular stand-alone shape, theblocking material may be comprise one or more of the following materialsamong others: one or more randomly coiled threads, one or more randomlybunched meshes, one or more meshes formed into a specially foldedconfiguration, one or more threads and/or meshes formed into athree-dimensional shape of circular, oval or annular cross-section(e.g., a preformed sphere, oblate spheroid, prolate spheroid, cylinder,annulus, etc.), and so forth.

For example, referring now to FIG. 1A, an embodiment is shown in which ablocking material 10 is pre-loaded into a delivery channel 30 of adelivery device. During delivery, the end of the delivery channel 30 isadvanced to a predetermined fallopian tube location 40 as schematicallyshown in FIG. 1A. Once at this location, the plunger 35 is advancedwithin the delivery channel 30, pushing the blocking material 10 fromthe delivery channel 30 as shown in FIG. 1B. In the embodiment shown,the blocking material 10 is a resilient material which is compressed inthe delivery channel 30 and expands to engage the internal surface ofthe fallopian tube 40 upon emerging from the delivery channel 30. Thedelivery channel 30 and plunger 35 are then withdrawn, leaving theblocking material 10 in the fallopian tube 40. As elsewhere herein, theprocedure can then be repeated on the contralateral side to occlude bothfallopian tubes.

In certain embodiments, a sealing material is delivered prior to, alongwith and/or after the blocking material. The sealing material is a fluidmaterial, for example, a gel or a biodegradable adhesive material (e.g.,curable composition that is flexible upon cure) which acts to blocksperm and egg movement immediately upon implantation while at the sametime allowing tissue growth (e.g., permanent scar tissue) into thespaces associated with the blocking material over a short period oftime. After delivery of the blocking material and sealing material, thesealing material may be positioned, for example, in one or more of thefollowing locations: (a) within the spaces (e.g., pores) associated withthe open (e.g., filamentous) blocking material, (b) within the fallopiantube at a position distal to (i.e., on the ovary side of) the blockingmaterial, and (c) within the fallopian tube at a position proximal to(i.e., on the uterus side of) the blocking material. In certain of theseembodiments, the mesh acts as scaffolding for the fluid sealingmaterial. For example, the mesh may prevent the fluid sealing materialfrom migrating.

For example, after the sealing material 10 has been placed in thefallopian tube 40 as shown in FIG. 1C, if desired, a device (e.g., acatheter) may be inserted into the fallopian tube to deliver an amountof sealing material 20 as shown in FIG. 1D. The subsequently injectedsealing material 20 may penetrate all of the sealing material 10 or aportion of the sealing material 10 p as shown.

In another embodiment shown in FIG. 2A, a sealing material 20 andblocking material 10 (whose spaces are partially or completely filledwith sealing material) are pre-loaded into a delivery channel 30 of adelivery device. During delivery, the end of the delivery channel 30 isadvanced to a predetermined fallopian tube location 40 as shown in FIG.2A. Once at this location, the plunger 35 is advanced within thedelivery channel 30, pushing the blocking material 10 and sealingmaterial 20 from the delivery channel 30 as shown in FIG. 2B. Thedelivery channel 30 and plunger 35 are then withdrawn, leaving theblocking material 10 and sealing material 20 in the fallopian tube 40 asshown in FIG. 2C. If desired, an additional device (e.g., a catheter)may be inserted into the fallopian tube (e.g., via a deliver channel 30)to deliver an additional amount of sealing material 20 as shown in FIG.2D.

As noted above, the sealing material is a fluid material, for example, agel or a biodegradable adhesive material which acts to block spermmovement, while at the same time allowing tissue growth into theblocking material. Preferably the sealing material is removed from thesite (e.g., bioeroded, biodisintegrated, biodegraded, etc.), forexample, at least 50% of the material (e.g., 50% to 75% to 90% to 95% to100%) is removed from the site over a period of 1 to 2 to 4 weeks.

Examples of sealing materials (e.g., gels, adhesives, etc.) may beselected, for example, from one or more of the following, among others:collagen, elastin, thrombin, fibronectin, gelatin, gelatin-thrombinmixtures, gelatin-resorcinol-formaldehyde-glutaraldehye (GRFG) glue,fibrin, fibrin glue, albumin and glutaraldehyde tissue adhesive,tropoelastin, gell-forming peptides including self-assembling peptidehydrogels, Ethibloc amino acid gel, laminin, proteoglycans,glycosaminoglycans, glycoproteins, fibrin glue, activated platelet gel,atelocollagen, starch, pectin, cellulose, alkyl cellulose, e.g.methylcellulose, hydroxyalkyl cellulose, alkylhydroxyalkyl cellulose,cellulose sulfate, carboxymethyl cellulose, carboxyethyl cellulose,chitin, carboxymethyl chitin, hyaluronic acid, alginic acid, agar,agarose, glycogen, dextran, dextran sulfate, carboxymethyl dextran,curdlan, pectin, pullulan, xanthan, chondroitin, chondroitin sulfate,carboxymethyl chitosan, chitosan, dermatan sulfate, keratan sulfate,carrageenan, starch, amylose, amylopectin, poly-N-glucosamine,polymannuronic acid, polyglucuronic acid, polyguluronic acid,poly(alkylene oxides) such as poly(ethylene oxide), polypropyleneoxide), poly(ethylene oxide-co-propylene oxide), poly(vinyl alcohol),ethylene vinyl alcohol copolymer, polyethylene glycol-based materials(e.g., FOCAL SEAL from Focal, Inc. and COSEAL from CohesionTechnologies, Inc.), monostearoyl glycerol co-succinate/polyethyleneglycol (MGSA/PEG) copolymers, as well as salt forms and crosslinkedforms of the foregoing.

In certain embodiments, a two-component curable adhesive composition isemployed as the sealant material. In these embodiments, it is preferredthat the curing kinetics are sufficiently slow to allow the twocomponents to be mixed, at which time the mixture can be delivered priorto, along with and/or after the blocking material as described above.For example, two liquid components may be mixed by mixing screw duringinjection. The liquids combine/interact when channeled through thethreads of the mixing screw.

In some embodiments, the sealing material is provided with a spermicideto enhance the effectiveness of the material. Examples of spermicidesinclude benzalkonium chloride, chlorhexidine digluconate, D-propranololHCl, muhric acid, menfegol, nonoxynol-9, and octoxynol-9.

In certain embodiments, the sealing material is a commercially availablespermicidal gel. Commercially available gels (which contain nonoxynol-9)include the following: ADVANTAGE 24 gel (Lake Consumer), CONCEPTROL gel(Advanced Care), GYNOL jelly (Advanced Care), GYNOL II ES jelly(Advanced Care), KOROMEX jelly (Quality Health), KOROMEX CRYSTAL CLEARgel (Quality Health), ORTHO-GYNOL jelly (Advanced Care), SHUR-SEAL jelly(Milex Products), VCF gel (Apothecus Pharmaceutical).

In some embodiments, the sealing material is provided with an agent topromote tissue in-growth. Examples of such agents includeproinflammatory agents and/or sclerosing agents.

Proinflammatory agents can be selected, for example, from suitableendotoxins, cytokines, chemokines, prostaglandins, lipid mediators, andother mitogens. Specific examples of proinflammatory agents from whichsuitable agents can be selected include the following: growth factorssuch as platelet derived growth factor (PDGF), fibroblast growth factor(FGF), transforming growth factor (such as TGF-alpha and TGF-beta),epidermal growth factor (EGF), insulinlike growth factor (IGF),interleukins such as IL-1-(alpha or beta), IL-8, IL-4, IL6, IL-10 andIL-13, tumor necrosis factor (TNF) such as TNF-alpha, interferons suchas INF-gamma, macrophage inflammatory protein-2 (MIP-2), leukotrienessuch as leukotriene B4 (LTB4), granulocyte macrophage-colony stimulatingfactor (GM-CSF), cyclooxygenase-1, cyclooxygenase-2, macrophagechemotactic protein (MCP), inducible nitric oxide synthetase, macrophageinflammatory protein, tissue factor, phosphotyrosine phosphates,N-formyl peptides such as formyl-Met-Leu-Phe (fMLP), secondmitochondria-derived activator of caspase (sMAC), activated complementfragments (C5a, C3a), phorbol ester (TPA), superoxide, hydrogenperoxide, zymosan, bacterial lipopolysaccharide, imiquimod, variouspharmaceutically acceptable salts and derivates of the foregoing, andcombinations of the foregoing, among other agents.

Suitable sclerosing agents for the practice of the invention can beselected, for example, from the following: inorganic materials such asaluminum hydroxide, sodium hydroxide, silver nitrate and sodiumchloride, as well as organic compounds, including alcohols such asethanol, acetic acid, trifluoroacetic acid, formaldehyde, dextrose,polyethylene glycol ethers (e.g., polidocanol, also known as laureth 9,polyethylene glycol (9) monododecyl ether, andhydroxypolyethoxydodecane), tetracycline, oxytetracycline, doxycycline,bleomycin, triamcinolone, minocycline, vincristine, iophendylate,tribenoside, sodium tetradecyl sulfate, sodium morrhuate, diatrizoatemeglumine, prolamine diatrizoate, alkyl cyanoacrylates such asN-butyl-2-cyanoactyalte and methyl 2-cyanoacrylate, ethanolamine,ethanolamine oleate, bacterial preparations (e.g., corynebacterium andstreptococcal preparations such as picibanil) and mixtures of the same,among others.

In certain embodiments, the invention is directed to elongated deviceswhich include a delivery chamber from which a filamentous blockingmaterial can be released, for example, the delivery chamber of such adevice may comprise a preloaded composition comprising (a) a blockingmaterial such as that described above, for instance, a filament or acollection of filaments (including a mesh) that is preloaded in aparticular shape, for example, in a shape of cylindrical, oval orannular cross-section (e.g., a filamentous ball, filamentous cylinder,etc.) and, optionally, (b) a fluid sealing material such as thatdescribed above (e.g., tissue adhesive, gel, etc.).

In certain embodiments, the invention is directed to a kit thatcomprises (a) a blocking material, for example, a filament or acollection of filaments (including a mesh) that is preformed in aparticular shape, for example, in a shape of cylindrical, oval orannular cross-section, among others, or a collection of filaments(including a mesh) that can be formed into a particular shape by theuser, for example, in a shape of cylindrical, oval or annularcross-section, either ex vivo (e.g., in the delivery chamber of adevice) or in vivo (e.g., in the fallopian tube), (b) a fluid sealingmaterial (e.g., tissue adhesive, gel, etc.) and (c) optionally, adelivery device (e.g., a catheter, a scope with a working channel, etc.)which is configured to deliver the blocking material and the fluidsealing material to the fallopian tube via a transcervical route.

Various particular mesh designs will now be discussed. In someembodiments, the mesh is provided with a molded tip and/or suture.

In addition, several additional delivery devices and various placementtechniques will be described, by which one or more meshes can bedelivered in numerous orientations, including random and organizedorientations (e.g., the mesh may be simply be laid in place, folded,bunched, twisted, etc.). A single piece of mesh may be placed or morethan one piece of mesh can be placed. Multiple meshes can be placed inparallel or in series.

In some embodiments, the delivery device may incorporate a hysteroscopefor viewing. In other embodiments, a hysteroscope may be provided withina lumen of the delivery device or used alongside of the delivery devicefor viewing. In others embodiments the delivery device is configured toincorporate a guidewire. In still other embodiments, the delivery deviceis radioapaque such that is can be delivered with a fluoroscope, inwhich case the mesh may also be radiopaque. In some embodiments, thedevice comprises a rigid elongated shaft. In other embodiments, thedevice comprises a flexible elongated shaft.

In each of the embodiments to follow, a fluid sealing material (e.g.,tissue adhesive, gel, etc.) may be delivered to the subject before,along with and/or after the delivery of the mesh to the subject.

In various embodiments of the invention, a rectangular mesh is employed.A schematic perspective view of such a mesh 110 is shown in FIG. 3. Forexample, the mesh may have a length of 20 to 50 mm (20 to 30 to 40 to 50mm), may have a width of 0.5 to 20 mm (e.g., 0.5 to 1 to 2 to 3 to 5 to8 to 10 to 15 to 20 mm), and may be formed from fibers having a diameterbetween 0.025 to 0.625 mm (0.025 to 0.05 to 0.10 to 0.25 to 0.50 to0.625 mm), more typically 0.05 mm to 0.25mm, which fibers may be wovento form spaces/pores ranging from 0.01 to 5 mm (e.g., 0.01 mm to 0.1 mmto 0.5 mm to 1 mm to 3 mm to 5 mm), more typically 0.5 to 3 mm in width.

The mesh may be formed from a single layer of material or multiplelayers. In various embodiments, a single layer mesh is employed. Thesmaller the diameter of the fiber used to manufacture the mesh, thecloser the weave that is possible, enabling the production of smallerpore sizes. It should also be understood that pore sizes can be madesmaller by compaction or folding of the mesh before or during delivery.For example, a single layer mesh may be placed as shown in FIG. 6 toform multiple layers. When two or more mesh layers having the same poresize are stacked (e.g., by folding a single mesh, by stacking multiplemeshes), the “through” pore size is effectively reduced because no twolayers of mesh will have pores that line up perfectly with each other.

In certain embodiments, a long piece of mesh may be provided to allowthe user to cut the mesh to any desired length and/or to providemultiple mesh units when cut.

When a mesh of this type is cut, tangs are produced during the cuttingprocess, leaving exposed pointed fibers extending from the edges. Tangscan be removed by a heating process to melt the extended fibers down toa fiber crossover point in a process known as de-tanging. De-tangingmelts and joins the fibers together and prevents the mesh fromun-raveling. De-tanged portions of the mesh can be manipulated withouttangs penetrating into surrounding tissue.

FIG. 3A is a detail of an edge portion of a mesh 110 that is formed froma knotted multifilament yarn 110 y. The mesh 110 has been cut from alarger mesh material, leaving tangs 100 t, which are shown at two of theknots at the edge of the mesh. Three of the knots shown at the edge ofthe mesh have been de-tanged 110 d by heating the tangs to above theirmelting point.

Other types of meshes can be molded, extruded, knitted or stamped. Tangscan be produced by cutting the mesh. Secondary operations can be used tocut off, melt or even laser off tangs, if desired.

FIG. 4 illustrates the mesh 110 of FIG. 3 wrapped in a semicirculararrangement. Such a shape may be created, for example, by wrapping themesh 110 around the inner tube 102 of a delivery device 100 (partialperspective view) like that shown in FIG. 9. The outer tube 104, whichacts as a sheath 104 in FIG. 9, covers the mesh 110 and its associatedtangs 110 t (at its edges) entirely during delivery, to preventinadvertent engagement of the mesh 110 with adjacent tissue. When thesheath 104 is pulled back (arrow A) the exposed portion of the mesh 110will tend to spring back to a flat state like that shown in FIG. 3. Theexposed tangs will engage surrounding tissue as the mesh 110 is releasedfrom the delivery device to secure the mesh 110 in place.

FIG. 5 illustrates the mesh 110 of FIG. 3 in a twisted or spiralorientation. As the mesh 110 of FIG. 9 is released from the deliverydevice 100, a portion of exposed tangs will engage tissue as notedabove. The mesh 110 may then be twisted by rotating the sheath 104 orrotating the entire delivery device 100 as shown by arrow C in FIG. 9.The cross-sectional area or occlusion area of the twisted mesh isincreased relative to the mesh in the absence of twisting. Continualtwisting will further shorten the length of the strip and compact themesh in a spiral. See FIG. 18 for a schematic illustration of a twistedmesh 110 positioned in the fallopian tube 150. Also shown in FIG. 18 arethe uterus 152 and ovary 154 of the subject.

It should be understood that in certain cases, the mesh may have a verysmall width (less than 0.7 mm wide). The mesh length can be displaced ina spiral configuration, spiraling from the outside diameter towards thecenter to occupy the fallopian tube's entire inner diameter, therebyocclude the fallopian tube. Conversely, such a mesh may be randomlyplaced/packed into the fallopian tube. In this case the mesh length maybe much longer than the preferred upper range of 50 mm described above.

FIG. 6 illustrates a mesh 110 like that of FIG. 3, in a bunched oraccordion-type orientation. An orientation of this type may be formed invivo as follows: As the sheath 104 is drawn back from the deliverydevice 110 of FIG. 9, that portion of the mesh with exposed tangs 110 ewill engage adjacent tissue. The sheath 104 of the delivery device 100can be reciprocated along arrows A and B, causing the mesh 110 to bunchin vivo. The cross-sectional area or occlusion area of the mesh 110 isincreased prior to that which would be achieved without bunching.Further bunching will further shorten the length of the mesh 110. SeeFIG. 20 for a schematic illustration of a bunched mesh 110 positioned inthe fallopian tube 150.

FIG. 7 illustrates the mesh 110 like that of FIG. 1, which has beenfolded over, thus doubling the mass per length and also doubling thenumber of tangs per length, even without twisting or bunching. Thisconfiguration has two mesh legs 110 a, 110 b. A mesh 110 in theconfiguration of FIG. 7 can also be delivered by a delivery device 100like that shown in FIG. 9. It should be understood that both legs 110 a,110 b of the mesh 110 of FIG. 7 can also be twisted or bunched using thedelivery device of FIG. 9. See FIG. 19 for an illustration of a mesh 110positioned in the fallopian tube 150 of a patient. In this embodiment, aguide wire can be passed through the pores/openings of the mesh 110and/or a scope can be passed through the openings of the mesh 110 tofacilitate device guidance.

FIG. 8 illustrates the mesh 110 of FIG. 3 folded over to a thickness of4 times, thus quadrupling the mass per length and also quadrupling thenumber of tangs per length. A loop suture is used to invert the mesh ofFIG. 7 to that of FIG. 8. The legs of FIG. 8 can also be twisted orbunched. See FIG. 21 for an illustration of the mesh of FIG. 8positioned in a fallopian tube 150 of a patient. The suture 112 in FIG.21, which is used to invert the mesh from a shape like that of FIG. 7 toa shape like that of FIG. 8, has not yet been removed.

FIG. 10 is a schematic perspective view of the entire delivery device100 of FIG. 9. FIG. 11 illustrates the delivery device of FIG. 10 with aview of the disassembled components. The delivery device 100 comprises asheath 104 with a hub 108 having a first ring 103 a. The delivery device100 also comprises an inner tube 102 with a fitting 106 (which acts as ahandle) attached at its proximal end 102 p. A lumen extends along theentire length of the inner tube 102 and the fitting 106. The lumen canbe sized for a guidewire only or for a hysteroscope (which wouldconfiguration would also accommodate a guidewire). The fitting mayprovide a second ring 103 b. The fitting 106 may also provide two ports107 b, 107 a. The back port 107 b may be used, for example, for theinsertion of a device such as a guidewire, scope, and/or suture. Theadditional port 107 a can be used, for example, for irrigation,inflation, suction, injection, drainage or other procedure. A lumen alsoextends along the entire length of the sheath 104 and hub 108. The lumenof the sheath 104 is sized to house a mesh assembly 110 z as it isseated on the outer surface of the inner tube 102. A spacer 109 isprovided to maintain the sheath 104 in a stationary position (in bothaxial directions) during introduction of the delivery device 100 throughthe cervix by means of two grooves 109 g which snap onto the ring 103 aof the hub 108 and ring 103 b of the fitting 106. When the spacer isremoved the sheath 104 and inner tube 102 can slide axially relative toeach other.

The mesh assembly 110 z illustrated in FIG. 10B, which is shown enlargedin FIG. 11, is somewhat different than the mesh shown in FIG. 7. Inaddition to a mesh 110, the mesh assembly 110 z illustrated in FIGS. 10Band FIG. 11 also includes an insert molded tip 111 and a looped suture112 threaded through the mesh. The tip 111 provides ease of insertionand has a through lumen to provide scope and/or guide wire access. Thetip 111 can be barbed to help maintain and anchor it within thefallopian tube. As with the mesh 110, the tip 111 may also be formedfrom a biostable polymer such as polypropylene. The suture 112 loopprovides the ability to position the mesh from an orientation like thatof FIG. 7 to an orientation like that of FIG. 8, in which case the tip112 should not be barbed to allow the end of the assembly to be pulledback. The suture 112 is preferred to be looped such that it can beeasily removed from a position external to the body. The suture 112 loopcan be cut external to the body and one end of the suture pulled toun-loop the suture 112 from the mesh 110 or mold tip 111. In someembodiments, the suture 112 can be used to retrieve the mesh 110, ifinadvertently placed or used for temporary placement.

In some embodiments the suture 112 can be used to maintain the mesh 110on the OD of the inner tube 102 and no sheath 104 is needed, forexample, by attaching a suture to each end of the legs and holding thesuture in tension external to the tube. In some embodiments, a suture112 is not used.

In some embodiments, a tip 111 is not used. In this regard, FIG. 12illustrates a mesh 110 like that of FIG. 7, which has been modified bycutting a hole 110 h and thermosetting in a mold to create to the shapeillustrated. The mesh 110 can be thermoset in the mold to haveadditional surface area, such as bumps or dimples. Two mesh legs 110 a,110 b are shown, which can be longer or shorter than the length shown.Other embodiment may have less or more than two mesh legs. In thisembodiment a looped suture is not employed, although in otherembodiments a looped suture may be employed, analogous to that shown inFIG. 11.

FIG. 13 illustrates a mesh 110 like that of FIG. 12 with only a singlemesh leg 110 a. The leg 110 a can be longer or shorter than shown. Asuture can also be looped into the mesh, analogous to that shown in FIG.11.

Other modifications are also possible. For example, slits may be cutinto the mesh leg(s) to create more tangs to engage tissue (not shown).

The components of the delivery device 100 shown in FIGS. 10A and 10B canbe assembled by the user or the manufacturer. For example, the suture112 (when present) of the mesh assembly 110 z may be threaded throughthe lumen of the inner tube 102 and out the device port 107 b of thefitting 106. The mesh 110 of the mesh assembly 110 z is positioned onthe OD and at the front end of the inner tube 102. The sheath 104 isslid over the mesh 110 and inner tube 102 to “sandwich” the mesh 110between the sheath 104 and inner tube 102. The spacer 109 is snappedonto the hub ring 103 a and fitting ring 103 b to secure the sheath 104in place.

The delivery device 100 of FIG. 10A can be advanced with that aid of ahysteroscope (not shown) inserted through the lumen of the inner tube102 and along the side of the suture. The hysteroscope will providevisualization to pass the device through the cervix and into thefallopian tube. (If the fallopian tube has already has been accessed bya guide wire, the delivery device can be slid over the guide wire forplacement.)

In another embodiment, the delivery device 100 is advanced over aguidewire 120 and the scope 130 is used alongside the delivery device100 for viewing as shown in FIG. 17.

Once the delivery device 100 is positioned in the fallopian tube 150, todeploy the mesh 110, the spacer 109 is removed, and the sheath 104 ismoved vis-à-vis the inner tube 102. With reference to FIG. 10A, the userhas several options or combinations of options for placement of themesh, which may include the following options, among others: To expose apart or the entire length of mesh 110, the sheath 104 is pulled by thehub towards the fitting 106 (in the direction of arrow A). Once aportion of the tangs engage the fallopian tube: (a) the sheath 104 (orthe entire device 100) can be rotated (in the direction of arrow C) totwist or spiral a portion of the mesh 110 as it is deployed, (b) asuture can be pulled (in the direction of arrow A) to convert the meshfrom a orientation like that of FIG. 7 to a orientation like that ofFIG. 8, in which case a length of B (see FIG. 8) of the mesh 110 may bede-tanged to allow the mesh 110 to slide when pulled, or (c) the sheath104 can be retracted (in the direction of arrow A) then advanced forward(in the direction of arrow B) to bunch the mesh 110 to a orientationlike that of FIG. 6. To complete the deployment of the mesh 110, afterthe sheath is fully withdrawn (in the direction of arrow A), the distalend of the inner tube 102 is then retracted (in the direction of arrowA) back into the sheath 104.

In another method for delivery, referring again to FIG. 10A, the spacer109 is first removed. Then, the sheath 104 is held stationary while theinner tube 102 is retracted (in the direction of arrow A) beyond themesh 110. A marking on the inner tube (not shown) can indicate thedesired extent of retraction. To deploy the mesh, the inner tube 102 isthen advanced forward (in the direction of arrow B) to push out andbunch the mesh 110. If preferred, the inner tube 102 can also be rotatedto twist the mesh 110. The mesh 110 can also be deployed by fullyretracting the sheath (in the direction of arrow A) to deposit the mesh,followed by retraction of the entire device 100.

In one embodiment of the delivery method, the mesh (and thus theassociated tangs) is reciprocated to cause injury to the fallopian tube,thereby spurring in-growth of tissue into the mesh to anchor and totallyocclude the lumen.

In another embodiment a brush (not shown) is used to cause uniforminjury to the fallopian tube before the mesh is placed (e.g., byadvancing and retracting the brush one or more times within thefallopian tube). In some instances, mesh is not placed after the use ofthe brush, with the fallopian tissue healing and closing within hours ordays as a result of the injury.

It is apparent from the above that there are multiple methods, includingcombinations of methods, for deploying a mesh using a delivery devicelike that describe in FIG. 10A to achieve various orientations for themesh, including combinations of orientations for the mesh.

FIG. 14A is another embodiment of a delivery device 100 in accordancewith the invention. FIG. 14B is a disassembled view of FIG. 14A. Thedelivery device 100 comprises a pusher 101 and a sheath 104 with afitting 106 attached at its proximal end 104 p. The lumen of the sheath104 is sized to accept a hysteroscope (not shown) and to accommodate thepusher 101 when the scope is removed. The sheath 104 may be placedvisually with a hysteroscope inserted in its lumen for placement throughthe cervix and into the fallopian tube, among other placement techniques(see above). Once the sheath 104 is positioned, the scope can beremoved. A mesh 110 can be transported through the lumen of the sheath104 with use of the pusher 101. A single mesh 110 or more than one mesh110 can be secured (e.g., skewered) at the tip of the pusher 101 andinserted into the lumen of the sheath 104. If desired, a sealingmaterial (e.g., gel, adhesive, etc.) may be inserted into the lumen 104prior to or along with the mesh 110. For instance, the mesh 110 may beloaded with sealing material (e.g., by dipping the mesh in sealingmaterial) and inserted into the lumen 104. The mesh 110 folds to conformto the width of the sheath 104 lumen and recovers some of its width onceit exits the distal tip 104 d of the sheath 104. The tangs of the mesh110 can engage surrounding tissue to anchor the mesh 110 in place withinthe fallopian tube. Withdrawal of the pusher 101 will complete thedeposition of the mesh within the fallopian tube. Additional 110 meshescan be deposited by reloading and advancing the pusher 101 by the user.

Meshes 110 of various shapes can be delivered with a device like that ofFIGS. 14A-14B, including various circular, oval, star-shaped andpolygonal shapes, such as those shown in FIGS. 15A-15H. Such meshes aretypically tanged, but may be de-tanged, if desired. Some of the meshes110 shown have sharp corners to further assist anchoring in a fallopiantube. Moreover, a variety of other mesh designs, including the meshes110 of FIGS. 7, 11, 12, 13, among others, can be used with a deliverydevice like that of FIGS. 14A-14B.

The meshes of FIGS. 15A-15H are shown in a flat configuration. Whensecured (e.g., skewered) at the tip of the pusher 101 as shown in FIG.14B and placed in the body, the mesh (so long as it has a diametergreater than that of the fallopian tube) becomes roughly conical inshape. In other embodiments, a cone shaped mesh having an open end(e.g., like an ice cream cone) is secured at the tip of the pusher.

It is noted that the pusher 101 may have two or more skewer posts on thedistal end of the pusher such that the mesh can be twisted by therotation of the pusher. It is also noted that the pusher of FIGS.14A-14B and the meshes of FIGS. 15A-15H (as well as other meshes) can beused with the delivery device of FIG. 7 to place additional meshes.

In some embodiments, two or more meshes are delivered, individually orat the same time. FIG. 22 illustrates the use of multiple meshes 110 toocclude the fallopian tube 150. The meshes 110 can have the same ordifferent pore sizes as noted above. The meshes 110 can be of differingshape (planer, spherical, cylindrical, etc.) and/or of differingorientation (e.g., twisted, bunched, etc.).

FIGS. 16A and 16B illustrate alternative mesh 110 embodiments, in whichthe meshes are provided in 3 dimensional shapes. The meshes 110 can berolled or shaped into a ball shape (FIG. 16A) or coiled and provided inan overall cylindrical shape (FIG. 16B). The meshes 110 preferablycomprise exposed tangs. The ball and coil shapes allow the meshes 110 tobe compressed and deployed through a sheath (see sheath 104 of FIG.14B), whereupon the meshes expand upon deployment in the fallopian tube.

As previously indicated, to enhance fallopian tube obstruction, asealing material may be delivered prior to, along with (e.g., aftersaturating the mesh with the sealing material) and/or after thedeposition of the meshes, in the embodiments described above.

Various aspects of the invention of the invention relating to the aboveare enumerated in the following paragraphs:

Aspect 1. A method for occluding a fallopian tube comprisingtranscervically delivering a solid blocking material and a fluid sealingmaterial into the fallopian tube.

Aspect 2. The method of aspect 1, wherein the solid blocking material isa mesh having exposed tangs.

Aspect 3. The method of aspect 2, wherein the mesh is twisted, folded orbunched at the time of delivery to the fallopian tube.

Aspect 4. The method of aspect 2, wherein multiple meshes are deliveredto the fallopian tube.

Aspect 5. The method of aspect 1, wherein the fluid sealing material isselected from a gel and a curable composition that is flexible uponcure.

Aspect 6. The method of aspect 1, wherein the fluid sealing materialcomprises an agent selected from a spermicide and a tissue in-growthpromoter.

Aspect 7. The method of aspect 1, wherein at least 90% of the fluidsealing material removed from the fallopian tube by the body over aperiod of two weeks.

Aspect 8. The method of aspect 1, wherein the fluid sealing material isdelivered prior to the solid blocking material, along with the solidblocking material, after the solid blocking material, or a combinationof the foregoing.

Aspect 9. The method of aspect 1, wherein the mesh is saturated with thefluid sealing material at the time of delivery to the fallopian tube.

Aspect 10. A kit for occluding a fallopian tube of a subject comprising(a) a solid blocking material, (b) a fluid sealing material, and (c) adelivery device that is configured to transcervically deliver the solidblocking material and the fluid sealing material into the fallopiantube.

Aspect 11. The kit of aspect 10, wherein the solid blocking materialcomprises a mesh.

Aspect 12. The kit of aspect 11, wherein the mesh comprises exposedtangs.

Aspect 13. The kit of aspect 11, wherein the mesh is a substantiallyplanar filamentous mesh.

Aspect 14. The kit of aspect 11, wherein the mesh is a substantiallynon-planar filamentous mesh comprising a substantially circular, oval orannular cross-section.

Aspect 15. The kit of aspect 11, wherein the mesh comprises two or morelegs and a suture loop.

Aspect 16. The kit of aspect 11, wherein the delivery device ispreloaded with the mesh.

Aspect 17. The kit of aspect 10, wherein the fluid sealing material isselected from a gel material and a curable composition that is flexibleupon cure.

Aspect 18. The kit of aspect 10, wherein the fluid sealing materialcomprises a spermicide.

Aspect 19. The kit of aspect 10, wherein the fluid sealing materialcomprises a tissue in-growth promoter.

Aspect 20. The kit of aspect 10, wherein the delivery device ispreloaded with the sealing material and a mesh.

Aspect 21. The kit of aspect 10, wherein the delivery device comprises(a) an elongated tubular member comprising a proximal end, a distal end,a lumen and a handle that comprises a port that accesses the lumen and(b) a pushing member configured to advance the solid blocking materialinto the port, through the elongated tubular member, and out of thedistal end of the elongated tubular member.

Aspect 22. The kit of aspect 21, wherein the delivery device furthercomprises a scope.

Aspect 23. A mesh delivery device comprising: (a) an elongated innertubular member comprising a proximal end, a distal end, a first lumen,and a stopping element disposed at or near its proximal end; (b) anelongated outer tubular member comprising a proximal end, a distal endand a second lumen that is sized to allow the distal end of the innertube to be inserted into the proximal end of the outer tubular memberand through the outer tubular member such that the distal end for theinner tubular member emerges from the distal end of the outer tubularmember when the stopping element of the inner tubular member engages theproximal end of the outer tubular member, (c) a spacer that isconfigured to engage the inner and outer tubular members such that theproximal end of the outer tubular member is spaced at a fixed axialdistance from the stopping element of the inner tubular member.

Aspect 24. The mesh delivery device of aspect 23, wherein the stoppingelement is a handle that comprises one or more ports that access thefirst lumen.

Aspect 25. The mesh delivery device of aspect 23, wherein the innertubular member comprises a first engagement member, wherein the outertubular member comprises a second engagement member, and wherein thespacer is configured to simultaneously engage the first and secondengagement members.

Aspect 26. The mesh delivery device of aspect 25, wherein the firstengagement member comprises a first ring, wherein the second engagementmember comprises a second ring, and wherein the spacer comprises firstand second grooves for receiving the first and second rings.

Aspect 27. The mesh delivery device of aspect 23, wherein the device ispreloaded with the mesh and wherein the mesh is positioned between theouter and inner tubular members proximal the distal end of the device.

Aspect 28. The mesh delivery device of aspect 27, wherein the meshcomprises two or more legs and a suture loop.

Aspect 29. The mesh delivery device of aspect 27, wherein the meshcomprises two or more legs and a molded tip.

Although various embodiments are specifically illustrated and describedherein, it will be appreciated that modifications and variations of thepresent invention are covered by the above teachings and are within thepurview of the appended claims without departing from the spirit andintended scope of the invention.

What is claimed:
 1. A method for occluding a fallopian tube comprisingtranscervically delivering a solid blocking material and a fluid sealingmaterial into the fallopian tube.
 2. The method of claim 1, wherein thesolid blocking material is a mesh having exposed tangs.
 3. The method ofclaim 2, wherein the mesh is twisted, folded or bunched at the time ofdelivery to the fallopian tube.
 4. The method of claim 2, whereinmultiple meshes are delivered to the fallopian tube.
 5. The method ofclaim 1, wherein the fluid sealing material is selected from a gel and acurable composition that is flexible upon cure.
 6. The method of claim1, wherein the fluid sealing material comprises an agent selected from aspermicide and a tissue in-growth promoter.
 7. The method of claim 1,wherein at least 90% of the fluid sealing material removed from thefallopian tube by the body over a period of two weeks.
 8. The method ofclaim 1, wherein the fluid sealing material is delivered prior to thesolid blocking material, along with the solid blocking material, afterthe solid blocking material, or a combination of the foregoing.
 9. Themethod of claim 1, wherein the mesh is saturated with the fluid sealingmaterial at the time of delivery to the fallopian tube.
 10. A kit foroccluding a fallopian tube of a subject comprising (a) a solid blockingmaterial, (b) a fluid sealing material, and (c) a delivery device thatis configured to transcervically deliver the solid blocking material andthe fluid sealing material into the fallopian tube.
 11. The kit of claim10, wherein the solid blocking material comprises a mesh.
 12. The kit ofclaim 11, wherein the mesh comprises exposed tangs.
 13. The kit of claim11, wherein the mesh is a substantially planar filamentous mesh.
 14. Thekit of claim 11, wherein the mesh is a substantially non-planarfilamentous mesh comprising a substantially circular, oval or annularcross-section.
 15. The kit of claim 11, wherein the mesh comprises twoor more legs and a suture loop.
 16. The kit of claim 10, wherein thefluid sealing material is selected from a gel material and a curablecomposition that is flexible upon cure.
 17. The kit of claim 10, whereinthe fluid sealing material comprises a spermicide or a tissue in-growthpromoter.
 10. The kit of claim 10, wherein the delivery device ispreloaded with the sealing material and a mesh.
 19. The kit of claim 10,wherein the delivery device comprises (a) an elongated tubular membercomprising a proximal end, a distal end, a lumen and a handle thatcomprises a port that accesses the lumen and (b) a pushing memberconfigured to advance the solid blocking material into the port, throughthe elongated tubular member, and out of the distal end of the elongatedtubular member.
 20. A mesh delivery device comprising: (a) an elongatedinner tubular member comprising a proximal end, a distal end, a firstlumen, and a stopping element disposed at or near its proximal end; (b)an elongated outer tubular member comprising a proximal end, a distalend and a second lumen that is sized to allow the distal end of theinner tube to be inserted into the proximal end of the outer tubularmember and through the outer tubular member such that the distal end forthe inner tubular member emerges from the distal end of the outertubular member when the stopping element of the inner tubular memberengages the proximal end of the outer tubular member, (c) a spacer thatis configured to engage the inner and outer tubular members such thatthe proximal end of the outer tubular member is spaced at a fixed axialdistance from the stopping element of the inner tubular member.